The Council for Responsible Nutrition (CRN) files challenges with NAD regarding advertising of dietary supplements to encourage manufacturers to provide substantiation for their advertising claims to an objective,third-party for review and evaluation and to assure that their claims are truthful, not misleading, and substantiated with credible scientific evidence. Here, following a challenge by CRN, NAD requested substantiation for certain claims made for "Cardio Miracle," a multi-ingredient powdered supplement sold by Evolution Nutriceuticals. The claims at issue concerned the purported ability of the supplement to help the body produce nitric oxide (NO) and the benefits of NO, particularly for cardiovascular health.
Although NAD reiterated its earlier finding that there is in fact scientific consensus that NO is "in every organ, essential to health and, in particular, essential to cardiovascular health," NAD determined that the advertiser failed to adequately support its claims.
First, Evolution did not submit any clinical testing on the Cardio Miracle product as a whole, thus failing to support its claims about the product itself. Second, advertiser failed to provide sufficient support for any ingredient claims. While "reliable and methodologically sound studies on the ingredients in a product may support properly qualified ingredient claims", advertisers must be able to show that those ingredients are "present in their products in the same amount, formulation and route of administration as the underlying ingredient studies," which the advertiser here failed to do.
NAD also was concerned that even if the advertiser had submitted studies on the ingredients in Cardio Miracle, the advertiser would have had to demonstrate the bioavailability and efficacy of those specific ingredients in its product.
Finally, NAD noted that the advertiser failed to submit the actual studies it relied upon for its ingredient claims. Instead, the advertiser referred NAD to informal summaries posted on the ingredient supplier's website. NAD noted that "a]bstracts and informal summaries do not impart enough information for NAD to properly evaluate whether they constitute competent and reliable scientific evidence."
As always, the more hard-hitting the claim, particularly one related to human health, the better and more reliable the proof must be to satisfy NAD. For a dietary supplement, the gold standard is a human clinical study demonstrating not only that the product contains the touted ingredients, but that those ingredients are "bio available" and that, when combined with the other ingredients in the product, still work to provide the advertised benefits.
As NAD observed in its decision, there is a scientific consensus that NO is in every organ and essential to cardiovascular and overall health. NAD’s inquiry did not challenge the scientific understanding of nitric oxide. Rather, the issue before NAD was whether the advertiser provided evidence sufficient to demonstrate that Cardio Miracle, or the ingredients in Cardio Miracle, would deliver the advertised health benefits to consumers.
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